Although head-to-head results on tolerability were missing from the company’s data release, Eli Lilly and Co. said its U.S. FDA-approved weight-loss drug Zepbound (tirzepatide) beat the also-cleared Novo Nordic A/S compound Wegovy (semaglutide) in a phase IIIb study comparing the two. Read More
Shares of Relmada Therapeutics Inc. (NASDAQ:RLMD) plummeted 77% to close at 63 cents Dec. 4 after a pre-planned interim analysis prompted the independent data monitoring committee to conclude the phase III Reliance II study testing REL-1017 in major depressive disorder is likely to fail, leaving the future of the NMDA receptor channel blocker in doubt while the company looks ahead to an earlier-stage psilocybin-based program targeting metabolic disease. Read More
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland China, Hong Kong and Macau. Read More
Duality Biologics is out-licensing preclinical antibody-drug conjugate (ADC) candidate DB-1324 under an option agreement with GSK plc potentially worth more than $1 billion. Read More
Elevar Therapeutics Inc. will license Relay Therapeutics Inc.’s “NDA-ready” bile duct cancer therapy, lirafugratinib (RLY-4008), through a potential $500 million deal as Elevar, an HLB Co. Ltd. subsidiary, seeks to diversify its oncology portfolio following the U.S. FDA rejection of its liver cancer drug candidate in May. Read More
Methods that may work well for recruiting and retaining white patients for clinical trials may need to be adjusted to maximize the involvement of patients from other ethnic backgrounds. At Biocom California’s Let’s Talk About series, panelists discussed the benefits and best practices for adding diversity to clinical trials. Read More
The U.S. CMS has negotiated outcomes-based agreements with Bluebird Bio Inc. and Vertex Pharmaceuticals Inc. to make their costly sickle cell gene therapies the first treatments to become available through the voluntary Medicaid Cell and Gene Therapy Access Model. Read More
Novartis AG lost its bid, at least for now, to delay generic competition to its blockbuster heart drug, Entresto (sacubitril, valsartan), on the basis of patent infringement. Read More
New hires and promotions in the biopharma industry, including: Beam, Biogene, Bioinvent, Cellino, Fairjourney, ITF, Klotho, Outlook, Preveceutical, Slingshot. Read More
Biopharmas raising money in public or private financings, including: Alligator, Jupiter, Maze, Rakovina, Revelation, Revolution, Serina, Trio. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anges, Cartesian, Enlivex, Inventisbio, Janux, Kinevant Sciences, Mesoblast, Palisade, Roivant, Terns, Valneva, Vasomune. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvogene, Corbus, Exegenesis, Hutchmed, Innovent, Intra-cellular, Lantern, Merck, PIF, Rezolute, Rhythm, Saol. Read More
